Abdominal Laparoscopic and/or Robotic SurgeryIPLANCT07775599

Intraperitoneal Lidocaine and Bupivacaine for Postoperative Pain After Laparoscopic Surgery

A study testing Lidocaine and Bupivacaine in people with Abdominal Laparoscopic and/or Robotic Surgery and Local Anasthesia, run by Misr University for Science and Technology at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Abdominal Laparoscopic and/or Robotic Surgery, Local Anasthesia, Post Operative Pain, Acute
What is being tested?: Lidocaine and Bupivacaine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteEgypt
Study dates: 6 Aug 2025to 5 Jul 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Adults aged 18 to 60 years.
Scheduled for laparoscopic abdominal surgery (e.g., laparoscopic cholecystectomy, laparoscopic appendectomy, or laparoscopic hernia repair).
American Society of Anesthesiologists (ASA) physical status I or II.
No history of chronic pain, opioid dependence, or severe medical comorbidities.
Able and willing to provide written informed consent.

Who cannot join

Conversion from laparoscopic to open surgery.
Acute cholecystitis, gangrene, or empyema of the gallbladder.
Oncologic or extensive laparoscopic procedures expected to have a prolonged operative time.
Known allergy or hypersensitivity to lidocaine, bupivacaine, or other local anesthetic agents.
Diabetes mellitus.
Current systemic corticosteroid use.

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Pregnancy.
Cardiac, pulmonary, hepatic, or renal disorders.
History of opioid use or opioid dependence.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

The Memorial Souad Kafafi University Hospital
Giza

Other trials in Egypt

About this study

Official title: The Effectiveness of Intraperitoneal Lidocaine and Bupivacaine Instillation for Reducing Postoperative Pain in Laparoscopic Abdominal Surgery: A Randomized Controlled Trial

The goal of this clinical trial is to determine the safety and efficacy of combined intraperitoneal local anesthetic instillation and port-site infiltration using lidocaine and bupivacaine in adults aged 18 to 60 undergoing elective laparoscopic abdominal surgeries (such as laparoscopic cholecystectomy, appendectomy, or hernia repair). The main questions it aims to answer are: Does combined intraperitoneal local anesthetic instillation and port-site infiltration reduce immediate and early (up to 4 hours) postoperative pain scores? Does this intervention reduce the early need for additional postoperative analgesics and shorten the length of hospital stay? Researchers will compare the treatment group receiving lidocaine (2%) and bupivacaine (0.5%) by intraperitoneal instillation and port-site infiltration with a control group receiving normal saline by the corresponding routes to determine whether the local anesthetic intervention reduces postoperative pain and analgesic requirements. Participants will undergo scheduled elective laparoscopic abdominal surgery and receive either the local anesthetic intervention or normal saline during the surgical procedure. Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery in the recovery room and again at 2 and 4 hours after surgery. Analgesic needs will be monitored and documented, and total hospital stay will be recorded.

Conditions: Abdominal Laparoscopic and/or Robotic Surgery, Local Anasthesia, Post Operative Pain, Acute, Lidocaine, Bupivacaine
Being tested: Lidocaine, Placebo Normal Saline (NS), Bupivacaine
Keywords: Abdominal Laparoscopic Surgery, local anasthesia, Pain, lidocaine, Bupivacaine
Medical subject headings: Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LidocaineDrug
10 mL lidocaine 2% administered intraoperatively by intraperitoneal instillation and port-site infiltration
Placebo Normal Saline (NS)Other
Intraoperative intraperitoneal instillation and port-site infiltration of normal saline
BupivacaineDrug
10 mL bupivacaine 0.5% administered intraoperatively by intraperitoneal instillation and port-site infiltration

Study groups in NCT07775599
Study group	Role	What they receive
Local Anesthetic Group	Active comparator	Participants in this arm will receive a total of 20 mL of study solution prepared by combining 10 mL of 2% lidocaine with 10 mL of 0.5% bupivacaine. The resulting 20-mL mixture will be divided equally between the intraperitoneal and port-site routes: 10 mL will be instilled intraperitoneally over the surgical bed, while the remaining 10 mL will be equally distributed among the trocar wounds for port-site infiltration. Receives: Drug: Lidocaine; Drug: Bupivacaine
Saline Group	Placebo comparator	Participants in this arm will receive a total of 20 mL of normal saline, divided equally between intraperitoneal instillation and port-site infiltration: 10 mL will instilled intraperitoneally over the surgical bed, while the remaining 10 mL will equally distributed among the trocar wounds. Receives: Other: Placebo Normal Saline (NS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Need for rescue opioid analgesia
Number of participants requiring rescue opioid analgesia for postoperative pain.
Measured: Immediately after surgery, 2 hours after surgery, and 4 hours after surgery

Secondary outcomes (3)

Postoperative pain intensity
Postoperative pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Immediately after surgery, 2 hours after surgery, and 4 hours after surgery
Length of hospital stay
Duration of hospitalization, measured from admission to discharge.
Measured: From admission until hospital discharge (up to 1 week)
Surgery duration
Duration of surgery measured in minutes from anesthesia induction until completion of wound dressing.
Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 20255 Jul 2026

First posted20 Aug 2026
Study start6 Aug 2025
Primary completion5 Jul 2026
Study completion5 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Abdominal Laparoscopic and/or Robotic SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07775599
Sponsor's protocol ID: 2025/0099
Acronym: IPLA
Status last verified: Aug 2026
First submitted: 7 Aug 2026
Last updated: 20 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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